This invention relates to diagnostic apparatus for use in radioimmunoassay for antigens and their antibodies. More particularly, this invention relates to a diagnostic apparatus for a direct radioimmunoassay for determining hapatitis associated antigen or its antibodies or antigens and antibodies.
Although there have been methods for determining the presence of antigenically active macromolecules such as intact viruses, virus capsids, subunits, bacteria, membranes, cell walls, hormones, etc., there has been a lack of a simple yet sensitive test method and apparatus for determining the presence of these materials. Viral hepatitis, including so called serum hepatitis, which is a relatively common disease, has not been heretofore easily detected by a sensitive test which is both specific and reproducible for quickly determining whether or not the serum from a patient or a donor contains hepatitis associated antigens or antibodies.
Furthermore, radioimmunoassay techniques have been developed in the past for various antigen-antibody materials. However, these radioimmunoassay techniques, such as disclosed in articles by Kevin Catt et al. in the Journal of Biochemistry, 1966, Volume 100, pages 31c and 33c and in Science, Volume 158, page 1570, 1967, are an indirect radioimmunoassay technique wherein the amount of antigen present is roughly proportional to the amount of radiation emitted by the tracer material. These procedures required the use of correlation tables and other materials which generally rendered the results less than reproducible and exact.
According to the present invention, it has been discovered that the above-noted difficulties, i.e., lack of reproducibility and exactness, have been overcome by utilizing the present diagnostic apparatus with the associated radioimmunoassay technique.
More specifically, the diagnostic test apparatus of the present invention comprises a receptacle tray having a series of wells for receiving samples, a holder arranged to receive, hold and deposit coated balls into the wells of the tray, a ball-release piece fitting over one end of the holder which is arranged when pressed to release the balls from the holder, and a cap to fit over the open end of the ball-release piece.